Duns Number:076836823
Device Description: The MIVI Canister Kit contains a vacuum pump canister and other disposable accessories to The MIVI Canister Kit contains a vacuum pump canister and other disposable accessories to be used with a Gomco 405 Aspiration Pump.
Catalog Number
-
Brand Name
MIVI Canister Kit
Version/Model Number
MCK-1500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
f5408b81-92f9-4b24-a51d-5fd19b6d888a
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
March 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |